Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither Neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors directors, agents and agentscontractors, nor, to the knowledge of the Company, any of their respective licensees (if any), nor any of their respective business operations, is in violation of any applicable laws, including Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and Act, the regulations promulgated thereunder, including the thereunder and any applicable non-U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereundercounterpart thereof; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); and (iv) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof thereof. Neither the Company nor any of its subsidiaries has received any warning letter, untitled letter or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement correspondence from any U.S. Governmental Authority alleging or state health care programasserting noncompliance with any Health Care Laws. Additionally, including but not limited to except as described in the federal TRICARE statute (10 U.S.C. §1071 et seq.)Registration Statement, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), Pricing Disclosure Package and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionallythe Prospectus, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, nor, to the knowledge of the Company, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the knowledge of the Company, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance in all material respects with all Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the U.S. criminal false statements law (42 U.S.C. § 1320a-7b(a)), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the U.S. exclusion law (42 U.S.C. § 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; Patient Protection and Affordable Care Act of 2010 (v) any laws or regulations that govern participation in or coverage or reimbursement from any Public Law 111-148), as amended by the U.S. or state health care program, including but not limited to the federal TRICARE statute Health Care and Education Reconciliation Act of 2010 (10 U.S.C. §1071 et seq.Public Law 111-152), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (v) the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesthe U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (vii) all other local, state, federal, national, supranational and foreign laws applicable to the Company and its subsidiaries. The Company and its subsidiaries have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The Company and its subsidiaries are not a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any and its subsidiaries nor, to the best of its subsidiariesknowledge, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiaries, or human clinical research or is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to as could not be in compliance would notexpected, individually or in the aggregate, result in to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7a), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder thereunder, including the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards for the Protection of Electronic Protected Health Information (the “Security Rule”), and the Standards for Electronic Transactions and Code Sets, and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; Patient Protection and Affordable Care Act of 2010 (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.Public Law 111-148), as amended by the Veterans Administration drug pricing program Health Care and Education Reconciliation Act of 2010 (38 U.S.C. Section 8126Public Law 111-152), and any the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) licensure, quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries. Neither the Company nor its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor its subsidiaries are a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of Company, its subsidiaries, subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting Except as described in the generality of subsection 1(a)(45) aboveRegistration Statement, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors Prospectus and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, the Pricing Disclosure Package or except where the failure to be in compliance as would not, individually or in the aggregate, result in be reasonably expected to have a Material Adverse Effect, each of the Company, its subsidiaries and the JVs is, and at all times has been, in compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: means all Applicable Laws of any Governmental Entity pertaining to health care regulatory matters applicable to the operations of the Company, its subsidiaries or its JVs, including (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, state and local and all foreign health care related fraud and abuse laws, including, without limitation, state corporate practice of medicine laws and regulations, state professional fee-splitting laws and regulations, state workers’ compensation laws and regulations, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Sxxxx Law (42 U.S.C. Section 1395nn), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA (as defined below), the U.S. exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), each as amended, and the implementing rules and regulations promulgated pursuant to such statutes; (ii) Medicare (Title XVIII of the Social Security Act); (iii) Medicaid (Title XIX of the Social Security Act), and the regulations promulgated thereunder; (iv) (a) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information1996, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)§§ 1320d-1329d-8, as amended by the Health Information Technology for Economic and Clinical Health Act, enacted as Title XIII of the American Recovery and Reinvestment Act of 2009, Public Law 111-5 (42 U.S.C. Section 17921 et seq.“HIPAA”), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (ivb) all applicable implementing laws and regulations; and (c) any similar state and local Applicable Laws regarding data protection, data processing, data privacy, data security and/or the U.S. Controlled Substances Actcollection, use, storage, disclosure or cross-border transfer of personal data and information, including protected health information (collectively, including HIPAA, the “Data Privacy and Security Laws”); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programand federal controlled substance and drug diversion laws, including but not limited to the federal TRICARE statute Federal Controlled Substances Act (10 21 U.S.C. §1071 § 801, et seq.), ) and the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) qualitythe Clinical Laboratory Improvement Amendments of 1988, safety 42 U.S.C. § 263a et seq.; (vii) any Applicable Law pertaining to or regulating the provision or administration of, or payment for, healthcare products and services (such services include physician and allied professional services and related ancillary services); (viii) and Applicable Law regulating the ownership or operation of a health care facility or business, or assets used in connection therewith, including licensing, certification and/or accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesrequirements; and (viiix) any and all other applicable health care laws and regulations regulations, each as amended from time to time, applicable to the operations of the Company, its subsidiaries or its JVs. Except as described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any jurisdictionsubsidiary or any of the JVs has received written notice from any Governmental Entity of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action alleging that any of the Company, the subsidiaries or the JVs is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any subsidiary or any of the JVs is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany Governmental Entity. Additionally, neither none of the Company nor any of Company, its subsidiaries, or the JVs nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting The Company and the generality of subsection 1(a)(45) aboveSubsidiaries are, neither the Company nor any of its subsidiariesand since January 1, nor any of their respective employees2017 have been, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, Laws except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended(21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the Federal False Statements Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section §§ 1320d et seq.), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act) and the regulations promulgated pursuant to such statutes; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersthereunder; (iv) the U.S. Controlled Substances Act; Physician Payments Sunshine Act (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 42 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126§ 1320a-7h), and any the regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiv) any and all other applicable health care laws and regulations regulation applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development by the Company. Neither the Company nor the Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor the Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither none of the Company nor any of or its subsidiaries, nor Subsidiaries or any of their respective employeesofficers or directors or, officersto the Company’s knowledge, directors, agents or contractors any of their respective employees has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employeesexclusion. The Company and the Subsidiaries have filed, officersobtained, directorsmaintained or submitted all reports, agents documents, forms, notices, applications, records, claims, submissions and supplements or contractors amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except in each case, as would not reasonably be expected to exclusion, suspension or debarmenthave a Material Adverse Effect.

Compliance with Health Care Laws. Without limiting The Company and, to the generality knowledge of subsection 1(a)(45) abovethe Company, neither the Company nor any of its subsidiariessubsidiary are, nor any of their respective employeesand at all times have been, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programPatient Protection and Affordable Care Act of 2010, including but not limited to as amended by the federal TRICARE statute (10 U.S.C. §1071 et seq.)Health Care and Education Affordability Reconciliation Act of 2010, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (viv) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesthe U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (viivi) any and all other applicable health care laws and regulations regulations. Neither the Company nor, to the knowledge of the Company, its subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor, to the knowledge of the Company, its subsidiary is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiariesemployees, nor officers or directors, nor, to the knowledge of the Company, its subsidiary or any of their respective the subsidiary’s employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the The Company nor any of its subsidiaries, nor any of their respective employees, officers, directors is and agents, nor any of their respective business operations, is has been in violation of any applicable compliance with all Health Care LawsLaws (as hereinafter defined), except where the failure to be in instances of non-compliance would not, individually singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitationAct, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local or federal health care laws and the regulations promulgated thereunder pursuant to such laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. The Company has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state federal health care program, including but except where such noncompliance, false claims liability or civil penalties would not limited reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging a material violation of any Health Care Laws, and, to the federal TRICARE statute (10 U.S.C. §1071 et seq.)Company’s knowledge, the Veterans Administration drug pricing program (38 U.S.C. Section 8126)no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to and has no ongoing reporting obligations pursuant to any regulations promulgated thereunder; (vi) qualitycorporate integrity agreements, safety and accreditation standards and requirements deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any applicable federal, state, local or foreign laws governmental or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such lawsauthority. Additionally, neither the Company nor nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program program, clinical trial or clinical registry or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or exclusion. Except as described in the Registration Statement, the Preliminary Prospectus and the Prospectus or as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company has not received any FDA Form 483, written notice of their respective employeesadverse finding, officerswarning letter, directors, agents untitled letter or contractors to exclusion, suspension other correspondence or debarmentwritten notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except where the failure to such noncompliance, false claims liability or civil penalties would not reasonably be in compliance would notexpected to, individually singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), Basic Health and Human Services Policy for Protection of Human Research Subjects “Common Rule” as codified and enforced by the Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. part 50, Laboratory Animal Welfare Act of 1966, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and Medicare (Title XVIII of the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Social Security Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), Medicaid (Title XIX of the Veterans Administration drug pricing program (38 U.S.C. Section 8126Social Security Act), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable comparable local, state, federal, national, supranational and foreign health care laws and the regulations in any jurisdiction, as well as contractual agreements mandated by promulgated pursuant to such laws, each as amended from time to time. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. The Company is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors reasonably be expected to exclusionresult in debarment, suspension or debarmentexclusion.

Compliance with Health Care Laws. Without limiting The Company and the generality of subsection 1(a)(45) aboveSubsidiaries are, neither the Company nor any of its subsidiariesand since January 1, nor any of their respective employees2013 have been, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, Laws except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended(21 U.S.C. §§ 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the Federal False Statements Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section §§ 1320d et seq.), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act) and the regulations promulgated pursuant to such statutes; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersthereunder; (iv) the U.S. Controlled Substances Act; Physician Payments Sunshine Act (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 42 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126§ 1320a-7h), and any the regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiv) any and all other applicable health care laws and regulations regulation applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development by the Company. Neither the Company nor the Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor the Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither none of the Company nor any of or its subsidiaries, nor Subsidiaries or any of their respective employeesofficers or directors or, officersto the Company’s knowledge, directors, agents or contractors any of their respective employees has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employeesexclusion. The Company and the Subsidiaries have filed, officersobtained, directorsmaintained or submitted all reports, agents documents, forms, notices, applications, records, claims, submissions and supplements or contractors amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission), except in each case, as would not reasonably be expected to exclusion, suspension or debarmenthave a Material Adverse Effect.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except where the failure to such noncompliance, false claims liability or civil penalties would not reasonably be in compliance would notexpected to, individually singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), Basic Health and Human Services Policy for Protection of Human Research Subjects "Common Rule" as codified and enforced by the Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. part 50, Laboratory Animal Welfare Act of 1966, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and Medicare (Title XVIII of the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Social Security Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), Medicaid (Title XIX of the Veterans Administration drug pricing program (38 U.S.C. Section 8126Social Security Act), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable comparable local, state, federal, national, supranational and foreign health care laws and the regulations in any jurisdiction, as well as contractual agreements mandated by promulgated pursuant to such laws, each as amended from time to time. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA, the TGA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. The Company is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors reasonably be expected to exclusionresult in debarment, suspension or debarmentexclusion.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand at all times has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, except where the failure to do so would not reasonably be in compliance would not, individually or in the aggregate, expected to result in a Material Adverse EffectChange. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. Section 301 et seq.), the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Public Health Service Act of 1987, as amended(42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal false statements law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuseU.S.C. Section 1320a-7b(a)), including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 17921 et seq.1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) the regulations promulgated thereunder Patient Protection and any state or non-U.S. counterpart thereof or other law or regulation Affordable Care Act of 2010, as amended by the purpose Health Care and Education Reconciliation Act of which is to protect the privacy of individuals or prescribers2010; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programlicensure, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; (v) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company, and (viivi) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The Company is not a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, or agents or contractors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is and at all times has been, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programPatient Protection and Affordable Care Act of 2010, including but not limited to as amended by the federal TRICARE statute (10 U.S.C. §1071 et seq.)Health Care and Education Affordability Reconciliation Act of 2010, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (viv) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesthe U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (viivi) any and all other applicable health care laws and regulations regulations. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except where the failure to such noncompliance, false claims liability or civil penalties would not reasonably be in compliance would notexpected to, individually singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “"Health Care Laws” means" means all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“"HIPAA”); (iv") the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), Basic Health and Human Services Policy for Protection of Human Research Subjects "Common Rule" as codified and enforced by the Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. part 50, Laboratory Animal Welfare Act of 1966, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and Medicare (Title XVIII of the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Social Security Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), Medicaid (Title XIX of the Veterans Administration drug pricing program (38 U.S.C. Section 8126Social Security Act), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable comparable local, state, federal, national, supranational and foreign health care laws and the regulations in any jurisdiction, as well as contractual agreements mandated by promulgated pursuant to such laws, each as amended from time to time. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA, the TGA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. The Company is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors reasonably be expected to exclusionresult in debarment, suspension or debarmentexclusion.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance in all material respects with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. Section 301 et seq.), the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Public Health Service Act of 1987, as amended(42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal false statements law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuseU.S.C. Section 1320a-7b(a)), including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 17921 et seq.1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (iv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws; and (v) the directives and regulations promulgated thereunder pursuant to such statutes and any state or non-U.S. counterpart thereof thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement action from any U.S. court or state health care programarbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.)knowledge of the Company, the Veterans Administration drug pricing program (38 U.S.C. Section 8126)is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any regulations promulgated thereunder; (vi) qualityof its subsidiaries is a party to any corporate integrity agreements, safety and accreditation standards and requirements of monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any applicable federal, state, local or foreign laws governmental or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such lawsauthority. Additionally, neither the Company nor any of its subsidiariessubsidiaries nor, nor to the knowledge of the Company, any of their respective employees, officers, directors, or agents or contractors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companywould reasonably be expected to result in debarment, any of its subsidiariessuspension, or any exclusion. Any certificate signed by an officer of their respective employeesthe Company and delivered to Cowen or to counsel for Cowen pursuant to or in connection with this Agreement shall be deemed to be a representation and warranty by the Company to Cowen as to the matters set forth therein. The Company acknowledges that Cowen and, officersfor purposes of the opinions to be delivered pursuant to Section 7 hereof, directorscounsel to the Company and counsel to Cowen, agents or contractors will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to exclusion, suspension or debarmentsuch reliance.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45(39) above, neither the Company nor any of its subsidiarieslicensees (if any), nor any of their respective employees, officers, directors and agents, nor any of their respective its business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal U.S. Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Sxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersindividuals; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any Titles XVIII and XIX of the U.S. or state health care program, including but not limited to Social Security Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (viii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiix) any and all other applicable health care laws laws, regulations, manual provisions, policies and regulations administrative guidance in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to do so would not reasonably be in compliance would not, individually or in the aggregate, result in expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder(“FDCA”), including the U.S. Prescription Drug Marketing Act of 1987, as amended21 U.S.C. §301 et seq., and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the federal criminal false claims law (42 U.S.C. § 1320a-7b), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the Xxxxx Law (42 U.S.C. § 1395nn), the exclusion laws (42 U.S.C. § 1320a-7), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, (ii) the U.S. Health Insurance Portability statutes, regulations and Accountability Act directives of 1996 (“HIPAA”)applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)HITECH Act, and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) any laws or regulations that govern participation in or coverage or reimbursement from any the U.S. or state health care program, including but not limited to the federal TRICARE statute Controlled Substances Act (10 21 U.S.C. §1071 Section 801 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any Medicare, Title XVIII of the Social Security Act, Medicaid, Title XIX of the Social Security Act; and (viii) all other applicable health care laws local, state, federal, national, supranational and regulations foreign laws, relating to the regulation of the Company or its subsidiary. Except as otherwise disclosed in any jurisdictionthe Registration Statement, as well as contractual agreements mandated by such laws. Additionallythe Pricing Disclosure Package and Prospectus, neither the Company nor any of its subsidiariessubsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all required and material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(451(a)(—) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors directors, agents and agentscontractors, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII, XIX and XXI of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vivii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws laws, regulations, manual provisions, policies and regulations administrative guidance in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance in all material respects with all Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the U.S. criminal false statements law (42 U.S.C. § 1320a-7b(a)), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.); , the U.S. exclusion law (iv42 U.S.C. § 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes, (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; , (iv) the U.S. Controlled Substances Act; Patient Protection and Affordable Care Act of 2010 (v) any laws or regulations that govern participation in or coverage or reimbursement from any Public Law 111-148), as amended by the U.S. or state health care program, including but not limited to the federal TRICARE statute Health Care and Education Reconciliation Act of 2010 (10 U.S.C. §1071 et seq.Public Law 111-152), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (v) the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.) and (vii) all other local, state, federal, national, supranational and foreign laws applicable to the Company and its subsidiaries. The Company and its subsidiaries have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The Company and its subsidiaries are not a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any and its subsidiaries nor, to the best of its subsidiariesknowledge, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiaries, or human clinical research or is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to do so would not reasonably be in compliance would not, individually or in the aggregate, result in expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder(“FDCA”), including the U.S. Prescription Drug Marketing Act of 1987, as amended21 U.S.C. §301 et seq., and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the federal criminal false claims law (42 U.S.C. § 1320a-7b), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the Xxxxx Law (42 U.S.C. § 1395nn), the exclusion laws (42 U.S.C. § 1320a-7), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, (ii) the U.S. Health Insurance Portability statutes, regulations and Accountability Act directives of 1996 (“HIPAA”)applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)HITECH Act, and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) any laws or regulations that govern participation in or coverage or reimbursement from any the U.S. or state health care program, including but not limited to the federal TRICARE statute Controlled Substances Act (10 21 U.S.C. §1071 Section 801 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any Medicare, Title XVIII of the Social Security Act, Medicaid, Title XIX of the Social Security Act; and (viii) all other applicable health care laws local, state, federal, national, supranational and regulations foreign laws, relating to the regulation of the Company or its subsidiary. Except as otherwise disclosed in any jurisdiction, as well as contractual agreements mandated the documents incorporated by such laws. Additionallyreference in the Time of Sale Information and the Offering Memorandum, neither the Company nor any of its subsidiariessubsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all required and material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting None of the generality of subsection 1(a)(45) aboveCompany, neither the Company nor any of its subsidiaries, nor nor, to Company’s knowledge, any director, officer, employee or agent of their respective employees, officers, directors and agents, nor any of their respective business operations, the Company is in violation of any applicable Health Care LawsLaws (as defined below), except where the failure to be in compliance would not, individually or in the aggregate, result in reasonably be expected have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; thereunder; (ii) all applicable federal, state, local and all foreign health health-care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections Section 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy Administrative Simplification provisions of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder including the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and any state or non-U.S. counterpart thereof or thereof, and any other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; prescribers; (ivv) the U.S. Controlled Substances Act; Act (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 21 U.S.C. Section 8126)801 et seq.); (vi) the U.S. Prescription Drug Marketing Act of 1987, as amended, and any the rules and regulations promulgated thereunder; (viviii) the Clinical Laboratory Improvement Act; and (ix) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (viix) any and all other applicable health care laws and regulations related to clinical research, testing, and medical product development activities, in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither none of the Company nor any of Company, its subsidiaries, nor any director, officer, employee or agent of their respective employees, officers, directors, agents or contractors the Company has been excluded, suspended or debarred from participation in any federal health care program orprogram. To the Company’s knowledge, no director, officer, employee or agent of the Company has been disqualified by FDA as a clinical investigator. Neither the Company, its subsidiaries, nor, to the knowledge Company’s knowledge, any director, officer, employee or agent of the Company and its subsidiaries, is subject to an or has been threatened in writing with a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companywould reasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and each Subsidiary are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to be Laws in compliance would not, individually or in the aggregate, result in a Material Adverse Effectall material respects. For purposes of this Agreement, “Health Care Laws” means, to the extent applicable to the Company’s operations: (i) the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. Section 301 et seq.), the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Public Health Service Act of 1987, as amended(42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal false statements law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuseU.S.C. Section 1320a-7b(a)), including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA Xxxxx Law (42 U.S.C. Section 1320d et seq.1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320a-7h); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)) ; (iv) all other comparable local, state, federal, national, supranational and foreign health care laws, relating to the regulation of the Company or the Subsidiaries, and (v) the directives and regulations promulgated thereunder pursuant to such statutes and any state or non-U.S. counterpart thereof thereof. Neither the Company nor any Subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement action from any U.S. Governmental Authority or state health care programthird party alleging that any product, including but not limited Company operation or activity is in material violation of any Health Care Laws nor, to the federal TRICARE statute (10 U.S.C. §1071 et seq.)Company’s knowledge, the Veterans Administration drug pricing program (38 U.S.C. Section 8126)is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and each Subsidiary have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any regulations promulgated thereunder; (vi) qualitySubsidiary is a party to any corporate integrity agreements, safety and accreditation standards and requirements of monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) Governmental Authority related to any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such lawsHealth Care Laws. Additionally, neither the Company nor any of its subsidiariesSubsidiary, nor any of their respective employees, officers, directors, or, to the Company’s knowledge, agents or contractors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45(hh) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse EffectChange. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal U.S. Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Sxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal administrative simplification provisions under of the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other applicable state law or regulation the purpose of which is to protect the privacy of individuals or prescribersindividuals; (iv) Titles XVIII and XIX of the U.S. Controlled Substances ActSocial Security Act and the regulations promulgated thereunder; (v) any laws or regulations that govern participation in or coverage or reimbursement from any the U.S. or state health care programMedicare Prescription Drug, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126)Improvement, and any Modernization Act of 2003 and the regulations promulgated thereunder; (vi) the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (vii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, applicable to the knowledge business of the Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarmentsubsidiaries as currently conducted.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the The Company nor any of and its subsidiaries, nor any of their respective employeesdirectors, officers, directors employees, contractors, and agentsagents are, nor any of their respective business operationsand for the previous three (3) years have been, is in violation of any compliance with all applicable Health Care Laws, as defined below, except where the failure to noncompliance would not reasonably be in compliance would notexpected to, individually or in the aggregate, result in a Material Adverse Effectmaterial adverse effect on the Company. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. §§ 301 et seq.), the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Public Health Service Act of 1987, as amended, (42 U.S.C. §§ 201 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, and local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. False Statements Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. §1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section § 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§1320d et seq.), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the exclusions law (42 U.S.C. § 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes, including but not limited to the coverage and payment provisions of Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act); (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) (42 U.S.C. Section §§ 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programlicensure, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodiesRegulatory Agencies; and (viivi) any and all other applicable health care laws and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product candidate manufactured or distributed by the Company. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental authority or Regulatory Agency or third party alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual agreements mandated by and, to the Company’s knowledge, no such lawsclaim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Additionally, neither Neither the Company nor any of nor, to the Company’s knowledge, its subsidiaries, nor any of their respective employees, officers, directors, agents employees, contractors or contractors agents, is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental authority or Regulatory Agency. Neither the Company nor, to the Company’s knowledge, any of its employees, contractors, agents, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject reasonably be expected to result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion. Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company possesses and is in compliance with all licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws except where such noncompliance would not be expected to, individually or in the aggregate, have a material adverse effect on the Company. The Company has not received any FDA Form 483, notice of its subsidiariesadverse finding, warning letter, untitled letter or other written correspondence or notice from the FDA or any other Regulatory Agency or governmental entity alleging or asserting material noncompliance with any Health Care Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws. Except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company, the Company has fulfilled and performed all of their respective employeesmaterial obligations with respect to all licenses, officerssublicenses, directorscertificates, agents permits and other authorizations and no event has occurred which allows, or contractors to exclusionafter notice or lapse of time would allow, suspension revocation or debarmenttermination thereof or results in any other impairment of the rights of the holder.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except where the failure to such noncompliance, false claims liability or civil penalties would not reasonably be in compliance would notexpected to, individually singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company which may include but are not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section §3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 286-287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv’) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section §1320d et seq.), ) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; exclusion laws (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 42 U.S.C. §1071 et seq.§ 1320a-7), Basic Health and Human Services Policy for Protection of Human Research Subjects “Common Rule” as codified and enforced by the Veterans Administration drug pricing program Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. Part 50, Laboratory Animal Welfare Act of 1966, Medicare (38 U.S.C. Section 8126Title XVIII of the Social Security Act), and any regulations promulgated thereunder; Medicaid (vi) qualityTitle XIX of the Social Security Act), safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable comparable local, state, federal, national, supranational and foreign health care laws and the regulations in any jurisdiction, as well as contractual agreements mandated by promulgated pursuant to such laws, each as amended from time to time. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Governmental Authority with jurisdiction over the Company or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA, the TGA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with Health Care Laws. The Company is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Authority with jurisdiction over the Company. Additionally, neither the Company nor Company, nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors reasonably be expected to exclusionresult in debarment, suspension or debarmentexclusion.

Compliance with Health Care Laws. Without limiting Except as set forth in the generality of subsection 1(a)(45) aboveRegistration Statement or the Prospectus, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable material compliance with all Health Care LawsLaws applicable to it and its business, except where the failure to be and has not engaged in compliance would notactivities which are, individually as applicable, cause for false claims liability, civil penalties, or in the aggregatemandatory or permissive exclusion from Medicare, result in a Material Adverse EffectMedicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. §§ 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) Medicare (Title XVIII of the U.S. Controlled Substances Social Security Act); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Medicaid (Title XIX of the federal TRICARE statute (10 U.S.C. §1071 et seq.Social Security Act), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viivi) any and all other applicable health care laws and regulations regulations. Except as set forth in the Registration Statement or the Prospectus, the Company has not received written notice of any jurisdictionclaim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual set forth in the Registration Statement or the Prospectus, the Company is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, except as set forth in the Registration Statement or the Prospectus, neither the Company nor nor, to the Company’s knowledge, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors has directors have been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand at all times has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care care-related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programPatient Protection and Affordable Care Act of 2010, including but not limited to as amended by the federal TRICARE statute (10 U.S.C. §1071 et seq.)Health Care and Education Affordability Reconciliation Act of 2010, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (viv) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesthe U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (viivi) any and all other applicable U.S. or non-U.S. health care laws and regulations regulations. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal or non-U.S. health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companywould reasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance Except as would not, individually or in the aggregate, not result in a Material Adverse EffectChange to the operations of the Company and its subsidiaries as a whole, the Company and its subsidiaries are, and at all times have been, in compliance in all respects with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended(21 U.S.C. Section 301 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal false statements law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuseU.S.C. Section 1320a-7b(a)), including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programlicensure, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (viiv) the directives and regulations promulgated pursuant to such statutes and any and all other applicable state or non-U.S. counterpart thereof. Neither the Company or its subsidiaries, or any of its respective officers, directors, employees or, to the knowledge of the Company, agents, have engaged in activities which are, as applicable, cause for Federal civil or criminal false claims liability, or mandatory or permissive exclusion from Medicare, Medicaid, TRICARE, any federal health care laws program (as defined in 42 U.S.C. § 1320a-7b(f)) as described in 42 U.S.C. § 1320a-7(b)(8) or any other state or federal healthcare program (collectively, the “Programs”). Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and regulations the Prospectus or as would not result in any jurisdiction, a Material Adverse Change to the operations of the Company and its subsidiaries as well as contractual agreements mandated by such laws. Additionallya whole, neither the Company nor any of its subsidiariessubsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened (“Action”). Except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and, except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor, except as would not result in a Material Adverse Change to the operations of the Company and its subsidiaries as a whole, any of their respective employees, officers, directors, or agents or contractors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company the Company, except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and its subsidiariesthe Prospectus, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand at all times has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in not be expected reasonably to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care care-related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. Section1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion law, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”) (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any applicable state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescriberspatients; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programPatient Protection and Affordable Care Act of 2010, including but not limited to as amended by the federal TRICARE statute (10 U.S.C. §1071 et seq.)Health Care and Education Affordability Reconciliation Act of 2010, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (viv) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesthe U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (viivi) any and all other applicable U.S. or non-U.S. health care laws and regulations relating to the ownership, testing, development, manufacture, quality, safety, accreditation, packaging, use, distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product manufactured or distributed by the Company. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal or non-U.S. health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companywould reasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither Neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors directors, agents and agentscontractors, nor, to the knowledge of the Company, any of their respective licensees (if any), nor any of their respective business operations, is in violation of any applicable laws, including Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and Act, the regulations promulgated thereunder, including the thereunder and any applicable non-U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereundercounterpart thereof; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); and (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards Standardsp for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof thereof. Neither the Company nor any of its subsidiaries has received any warning letter, untitled letter or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement correspondence from any U.S. governmental or state health care programregulatory authority alleging or asserting noncompliance with any Health Care Laws. Additionally, including but not limited to except as described in the federal TRICARE statute (10 U.S.C. §1071 et seq.)Registration Statement, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), Pricing Disclosure Package and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionallythe Prospectus, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, nor, to the knowledge of the Company, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, or, to the knowledge of the Company, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance in all material respects with all applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and (21 U.S.C. Section 301 et seq.), the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Public Health Service Act of 1987, as amended(42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal false statements law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuseU.S.C. Section 1320a-7b(a)), including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 17921 et seq.1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (iv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws; and (v) the directives and regulations promulgated thereunder pursuant to such statutes and any state or non-U.S. counterpart thereof thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement action from any U.S. court or state health care programarbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.)knowledge of the Company, the Veterans Administration drug pricing program (38 U.S.C. Section 8126)is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any regulations promulgated thereunder; (vi) qualityof its subsidiaries is a party to any corporate integrity agreements, safety and accreditation standards and requirements of monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any applicable federal, state, local or foreign laws governmental or regulatory bodies; and (vii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such lawsauthority. Additionally, neither the Company nor any of its subsidiariessubsidiaries nor, nor to the knowledge of the Company, any of their respective employees, officers, directors, or agents or contractors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companywould reasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the The Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable material compliance with all Health Care LawsLaws applicable to it and its business, except where the failure to be and has not engaged in compliance would notactivities which are, individually as applicable, cause for false claims liability, civil penalties, or in the aggregatemandatory or permissive exclusion from Medicare, result in a Material Adverse EffectMedicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. §§ 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) Medicare (Title XVIII of the U.S. Controlled Substances Social Security Act); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Medicaid (Title XIX of the federal TRICARE statute (10 U.S.C. §1071 et seq.Social Security Act), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viivi) any and all other applicable health care laws and regulations regulations. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any jurisdictionHealth Care Laws, as well as contractual and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor nor, to the Company’s knowledge, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors has directors have been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company and its subsidiaries, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting The Company and its subsidiaries are, and during the generality last three years have been in compliance and have taken any required and necessary actions to comply, and all of subsection 1(a)(45) abovethe Company’s and its subsidiaries’ products that are subject to the jurisdiction of the FDA or other governmental or regulatory authority are being manufactured, neither imported, exported, processed, developed, investigated, produced, labeled, stored, tested, marketed, promoted, advertised, distributed and sold by or on behalf of the Company nor any of or its subsidiariessubsidiaries in compliance, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable with all Health Care Laws, except where the failure to be in compliance noncompliance would not, individually not singly or in the aggregate, aggregate reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company or any of its subsidiaries, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitationAct, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Act (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, federal or foreign (including Israeli) health care laws and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is pursuant to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programsuch laws, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.)including, without limitation, the Veterans Administration drug pricing program (38 U.S.C. Section 8126)FDA’s current good manufacturing practice regulations at 21 CFR Part 820, good clinical practice regulations at 21 CFR Parts 50, 54, 56 and any 812, good laboratory practice regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any at 21 CFR Part 58 and all other applicable health care laws and regulations in applicable to non-clinical research, clinical research, establishment registration, device listing, pre-market notification, ownership, testing, development, manufacture, packaging, labeling, advertising, record-keeping, processing, use, distribution, adverse event reporting, reporting of corrections and removals, storage, import, export or disposal of the Company’s or any jurisdictionof its subsidiaries’ products, each as well as contractual agreements mandated by such lawsamended from time to time. Additionally, neither Neither the Company nor any of its subsidiaries has received any Form 483, notice of adverse finding, warning letter, untitled letter, requests or requirements to make changes to the Company’s or its subsidiaries’ products, manufacturing processes or procedures related to any product of the Company or its subsidiaries or other correspondence or notice from the FDA, or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging a material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor its subsidiaries are subject to any obligation arising under an administrative or regulatory action, government or regulatory inspection, warning letter, notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable governmental or regulatory authority; the Company and its subsidiaries have made all notifications, submissions, responses and reports required by FDA or other governmental or regulatory authority, including any such obligation arising under any administrative or regulatory action, inspection, warning letter, notice of violation letter or other notice, response or commitment made to or with the FDA or other governmental or regulatory authority, and all such notifications, submissions, responses and reports were true, complete and correct in all material respects as of the date of submission to the FDA or other governmental or regulatory authority. To the knowledge of the Company, no basis for liability exists with respect to any such notification, submission or report. During the last three years, no manufacturing site owned by the Company, its subsidiaries or, to the knowledge of the Company, any of their respective employeescontract manufacturers, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or other governmental or regulatory authority. Neither the Company, any of its subsidiaries or any of its or their respective officers, directors, agents managing employees (as such terms are defined in 42 CFR § 1001.2), nor to the knowledge of the Company, any agent (as such term is defined in 42 CFR § 1001.2) of the Company or contractors its subsidiaries is a party to or has ongoing obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none the Company or any of its subsidiaries, or, to the knowledge of the Company, any of its or its subsidiaries’ employees, officers or directors (i) has been charged with or convicted of any criminal offense relating to the delivery of an item or service under any federal health care program, (ii) has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical trial or, to the knowledge of Company and its subsidiariesthe Company, is subject to an inquiry, investigation, proceeding, or other similar matter action by any governmental authority that could reasonably be expected to result in debarment, suspension, or exclusion, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) is currently listed on the list of parties excluded from federal procurement programs and non-procurement programs as maintained in the Government Services Administration’s System for Award Management or other federal agencies, (v) to the knowledge of the Company, is the target or subject of any current or potential investigation relating to any federal health care program-related offense or (vi) has engaged in any activity that is in material violation of, or is cause for civil penalties or mandatory or permissive exclusion under, federal or state Laws. To the knowledge of the Company, any third Person that is a manufacturer or contractor for the Company or its subsidiaries is in compliance with all Health Care Laws and any other applicable Law insofar as they pertain to the manufacture of product components or products for the Company or its subsidiaries, except where noncompliance would not singly or in the aggregate reasonably be expected to result in a Material Adverse Effect. The Company and its subsidiaries have not either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, market withdrawal, or replacement, field notifications, field corrections, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety or efficacy or material regulatory compliance of any product or product candidate; and the Company and its subsidiaries are not aware of any facts which are reasonably likely to cause (i) the material recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such products or (iii) termination or suspension of the marketing or such products. Except as has not been, and would not reasonably be expected to be, individually or in the aggregate material to the Company and its subsidiaries, taken as a whole, (i) all agreements or other arrangements between the Company or any of their respective employeesits subsidiaries on the one hand and any physician on the other hand for services are in writing, officersdescribe bona fide services required by the Company or its subsidiaries, directorsas the case may be, agents provide for compensation that is no more than fair market value for such services determined as of the effective date of the agreement, and are in material compliance with the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b)) (“AKS”), (ii) all payments made and things of value provided by the Company or contractors any of its subsidiaries to exclusionany healthcare professional for services rendered by such health care professional have been made at fair market value determined as of the effective date of any such agreement and are in material compliance with AKS and (iii) all such agreements, suspension or debarmentarrangements, payments and things of value are in compliance in all material respects with all applicable Laws, including all Health Care Laws. The Company and its subsidiaries has timely, accurately and completely reported all payments and transfers of value made to physicians and teaching hospitals, as required by the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and the Company is in full compliance with all analogous state laws requiring the reporting of financial interactions with health care providers.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except where the failure to such noncompliance, false claims liability or civil penalties would not reasonably be in compliance would notexpected to, individually singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and Medicare (Title XVIII of the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Social Security Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), Medicaid (Title XIX of the Veterans Administration drug pricing program (38 U.S.C. Section 8126Social Security Act), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable comparable local, state, federal, national, supranational and foreign health care laws and the regulations in any jurisdiction, as well as contractual agreements mandated by promulgated pursuant to such laws, each as amended from time to time. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. The Company is not a party to and have no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors reasonably be expected to exclusionresult in debarment, suspension or debarmentexclusion.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to any non-compliance could not reasonably be in compliance would notexpected, individually or in the aggregate, result in to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws, the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programPatient Protection and Affordable Care Act of 2010, including but not limited to as amended by the federal TRICARE statute (10 U.S.C. §1071 et seq.)Health Care and Education Reconciliation Act of 2010, the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) licensure, quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries. Neither the Company nor its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, except as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were timely, complete, accurate and not misleading on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor its subsidiaries are a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of Company, its subsidiaries, subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employeesexclusion, officersexcept, directorsin each case, agents or contractors to exclusionfor such debarment, suspension or debarmentexclusion that could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand at all times has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance in all material respects with all Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic exclusion laws, the statutes, regulations and Clinical Health Act (42 U.S.C. Section 17921 et seq.)directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated thereunder pursuant to such statutes; (iii) the Patient Protection and any state or non-U.S. counterpart thereof or other law or regulation Affordable Care Act of 2010, as amended by the purpose Health Care and Education Affordability Reconciliation Act of which is to protect 2010, the privacy of individuals or prescribersregulations promulgated thereunder; (iv) the U.S. Controlled Substances Act; Act (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 21 U.S.C. §1071 Section 801 et seq.), the Veterans Administration drug pricing program ; and (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (viv) quality, safety and accreditation standards and requirements of any applicable federalall other local, state, local or federal, national, supranational and foreign laws applicable to the Company; provided that Health Care Laws does not include the health information data privacy and security provisions of HIPAA or other Privacy Laws. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory bodies; authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and (vii) supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The Company is not a party to any jurisdictioncorporate integrity agreements, as well as contractual monitoring agreements, consent decrees, settlement orders, or similar agreements mandated with or imposed by such lawsany governmental or regulatory authority. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure Except as would not reasonably be expected to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this AgreementChange, “Health Care Laws” means: the Company and its Subsidiaries and, to the Company’s knowledge, its and its Subsidiaries’ directors, employees and agents (iwhile acting in such capacity) the Federal Foodare and at all times have been in compliance with all health care laws, Drugrules, and Cosmetic Act and regulations applicable to the regulations promulgated thereunderCompany, including its Subsidiaries, or any of its products or product candidates or activities or operations as of the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse lawsdate hereof, including, without limitationbut not limited to, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the administrative False Claims Law (42 of U.S.C. Section 1320a-7b(a)), the United States Code and Xxxxx law (42 U.S.C. Section 1395nn), the regulations promulgated pursuant to such statutes; Physician Payments Sunshine Act (iii) any criminal laws relating to health care fraud and abuse42 U.S.C. Section 1320a-7h), including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), ) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; Cosmetic Act (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 21 U.S.C. §1071 Section 301 et seq.), the Veterans Administration drug pricing program Public Health Service Act (38 42 U.S.C. Section 8126201 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunder; pursuant to such laws, and any other similar state, federal or foreign law (vi) qualitycollectively, safety and accreditation standards and requirements “Health Care Laws”). The Company has not received any notification, correspondence or any other communication, including notification of any applicable federalpending or threatened claim, statesuit, local proceeding, hearing, enforcement, investigation, arbitration or foreign laws other action from any governmental authority or regulatory bodies; Regulatory Agency, including, without limitation, the FDA, the U.S. Federal Trade Commission, CMS, HHS’s Office of Inspector General, the U.S. Department of Justice and (vii) any and all other applicable health care laws and regulations in any jurisdictionstate Attorneys General or similar agencies of potential or actual non-compliance by, as well as contractual agreements mandated by such laws. Additionallyor liability of, neither the Company nor or any of its subsidiariesSubsidiaries under any Health Care Laws, nor except, with respect to any of their respective employeesthe foregoing, officerssuch as would not, directorsindividually or in the aggregate, agents or contractors has been excluded, suspended or debarred from participation result in any federal health care program or, a Material Adverse Change. The statements with respect to the knowledge of Company Health Care Laws and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, ’s compliance therewith included or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarmentincorporated by reference in the Prospectus are true and correct in all material respects.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance Except as would not, individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect, each of the Company, its subsidiaries and their respective directors, officers, employees, agents, contractors or licensees (if any), is and has been in compliance with applicable Health Care Laws (as defined below). For purposes of this Agreement, “Health Care Laws” means: means (i) the United States Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code Code, the Xxxxx Law (42 U.S.C. Section 1395nn) and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy Administrative Simplification provisions of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersprescribers or information related to health or medical records; (ivv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety Titles XVIII and accreditation standards XIX of the U.S. Social Security Act and requirements the regulations promulgated thereunder; (vii) the Clinical Laboratory Improvement Act and the regulations promulgated thereunder; (viii) the Medicare Access and CHIP Reauthorization Act of any applicable federal, state, local or foreign laws or regulatory bodies2015; (ix) the Emergency Medical Treatment and Labor Act; (x) the Fair Debt Collection Practices Act; (xi) the Telephone Consumer Protection Act; and (viixii) any amendments to such laws and all other applicable health care laws and regulations regulations, in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or other governmental or regulatory authority or third party alleging that any services, products, operations or activities of the Company or any of its subsidiaries is in material violation of any Health Care Laws nor, to the knowledge of the Company or its subsidiaries, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, plan of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none of the Company, its subsidiaries or their respective employees, officers, directors, agents or contractors has been excluded, suspended suspended, debarred or debarred disqualified from participation in any federal health care program or, to or disqualified or restricted under the knowledge of Company and its subsidiaries, Health Care Laws or is subject to or has been threatened in writing with an inquiry, claim, investigation, proceeding, proceeding or other similar matter that could would subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors contractors, to exclusion, suspension suspension, debarment, disqualification or debarmentrestriction.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Sxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII, XIX and XXI of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vivii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws and regulations in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company is, neither the Company nor any of its subsidiariesand has been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state, federal or national health care program, except where the failure to such noncompliance, false claims liability or civil penalties would not reasonably be in compliance would notexpected to, individually singly or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” meansmeans all health care laws applicable to the Company, including, but not limited to: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation21 U.S.C. Section 301 et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), Basic Health and Human Services Policy for Protection of Human Research Subjects “Common Rule” as codified and enforced by the Department of Health and Human Services in 45 C.F.R. part 46 and enforced by FDA under 21 C.F.R. part 50, Laboratory Animal Welfare Act of 1966, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and Medicare (Title XVIII of the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Social Security Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), Medicaid (Title XIX of the Veterans Administration drug pricing program (38 U.S.C. Section 8126Social Security Act), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable comparable local, state, federal, national, supranational and foreign health care laws and the regulations in any jurisdiction, as well as contractual agreements mandated by promulgated pursuant to such laws, each as amended from time to time. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company has not received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, the European Commission, the EMA or any other Health Regulatory Agencies, or any other court or arbitrator, alleging or asserting material noncompliance with the Health Care Laws. The Company is not a party to and have no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor Company, nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or trial or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors reasonably be expected to exclusionresult in debarment, suspension or debarmentexclusion.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(451(a)(46) above, neither the Company Company, nor any of its subsidiariesofficers, nor employees, directors, agents, contractors or licensees (if any), nor, to the Company’s knowledge, any of their respective employees, officers, directors and agents, nor any of their respective its business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b1320a- 7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health InformationInformation (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vivii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws laws, regulations, manual provisions, policies and regulations administrative guidance in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company Company, nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an inquiry, investigation, proceeding, or other similar matter that could would reasonably be expected to subject the Company, or any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting Except as set forth in the generality of subsection 1(a)(45) aboveRegistration Statement, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors General Disclosure Package and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, the Prospectus or except where the failure to be in compliance as would not, individually or in the aggregate, result in be reasonably expected to have a Material Adverse Effect, each of the Company, its Subsidiaries and its JVs is, and at all times has been, in compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: means all Laws of any Governmental Entity pertaining to health care regulatory matters applicable to the operations of the Company, its Subsidiaries or its JVs, including (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, state and local and all foreign health care related fraud and abuse laws, including, without limitation, state corporate practice of medicine laws and regulations, state professional fee-splitting laws and regulations, state workers’ compensation laws and regulations, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is pursuant to protect the privacy of individuals or prescriberssuch statutes; (ivii) Medicare (Title XVIII of the U.S. Controlled Substances Social Security Act); (viii) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Medicaid (Title XIX of the federal TRICARE statute (10 U.S.C. §1071 et seq.Social Security Act), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiiv) any and all other applicable health care laws and regulations regulations, each as amended from time to time, applicable to the operations of the Company, its Subsidiaries or its JVs. Except as set forth in the Registration Statement, the General Disclosure Package and the Prospectus, none of the Company or any jurisdictionof its JVs or, to the knowledge of the Company, any Subsidiary has received written notice from any Governmental Entity of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action alleging that the Company, its Subsidiaries or its JVs is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual set forth in the Registration Statement, the General Disclosure Package and the Prospectus, none of the Company or any of its JVs or, to the knowledge of the Company, any Subsidiary is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany Governmental Entity. Additionally, neither none of the Company Company, its JVs or its Subsidiaries nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance Except as would not, whether individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect, the Company and its subsidiaries are, and at all times during the past three years have been, in compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder(21 U.S.C. Section 301 et seq.); (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Statements Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. Section 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 286, 287 and 2871349, and the health care fraud criminal provisions under HIPAA (defined below), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), and the laws governing U.S. government funded or sponsored healthcare programs; (iii) all other comparable local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries; (iv) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information1996, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.collectively, HIPAA”), ; and (v) the regulations promulgated thereunder pursuant to such statutes and any state or non-U.S. counterpart thereof or other law or regulation thereof. None of the purpose Company, any of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programits subsidiaries, including but not limited nor, to the federal TRICARE statute (10 U.S.C. §1071 et seq.)Company’s knowledge, the Veterans Administration drug pricing program (38 U.S.C. Section 8126)any of their respective officers, and any regulations promulgated thereunder; (vi) qualitydirectors, safety and accreditation standards and requirements of any applicable federal, state, local employees or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations agents have engaged in any jurisdictionactivities which are, as well applicable, cause for liability under an applicable Health Care Law during the past three years, except, in each case, as contractual agreements mandated by such lawswould not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. AdditionallyDuring the past three years, neither the Company nor any of its subsidiariessubsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any applicable Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. During the past three years, the Company and its subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all respects (or were corrected or supplemented by a subsequent submission), except where the failures to so file, maintain, submit, correct or supplement the same would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of their respective employeesits subsidiaries is a party to any corporate integrity agreements, officersmonitoring agreements, directorsconsent decrees, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceedingsettlement orders, or other similar matter that could subject agreements with or imposed by any governmental or regulatory authority or body. Additionally, during the past three years, none of the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or, to the Company’s knowledge, independent contractors, affiliates or contractors agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, suspension or, to the Company’s knowledge, engaged in any conduct that would reasonably be expected to result in such debarment, suspension, or debarmentexclusion.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45(34) aboveabove and except as described in the Registration Statement, the U.S. Prospectus, the Canadian Prospectus and the Statutory Prospectus, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agentslicensees, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal U.S. federal Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder, including and the U.S. Prescription Drug Marketing Canadian Food and Drugs Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all U.S. federal and Canadian federal, state, provincial, territorial and local and all foreign health health-care related fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Sxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersindividuals; (iv) the U.S. Controlled Substances Act and the Canadian Controlled Drugs and Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any Titles XVIII and XIX of the U.S. or state health care program, including but not limited to Social Security Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) the U.S. federal Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (viii) quality, safety and accreditation standards and requirements of any all applicable U.S. and Canadian federal, state, provincial, territorial and local or foreign and all non-U.S. laws or regulatory bodies; and (viiix) any and all other applicable health care laws laws, regulations, manual provisions, policies and regulations administrative guidance in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) above, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance Except as would not, individually or in the aggregate, result in reasonably be expected to have a Material Adverse Effect, each of the Company, its subsidiaries and their respective directors, officers, employees, agents, contractors or licensees (if any), is and has been in compliance with applicable Health Care Laws (as defined below). For purposes of this Agreement, “Health Care Laws” means: means (i) the United States Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code Code, the Xxxxx Law (42 U.S.C. Section 1395nn) and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy Administrative Simplification provisions of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersprescribers or information related to health or medical records; (ivv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety Titles XVIII and accreditation standards XIX of the U.S. Social Security Act and requirements the regulations promulgated thereunder; (vii) the Clinical Laboratory Improvement Act and the regulations promulgated thereunder; (viii) the Medicare Access and CHIP Reauthorization Act of any applicable federal, state, local or foreign laws or regulatory bodies2015; (ix) the Emergency Medical Treatment and Labor Act; (x) the Fair Debt Collection Practices Act; (xi) the Telephone Consumer Protection Act; and (viixii) any amendments to such laws and all other applicable health care laws and regulations regulations, in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, demand, inquiry, arbitration or other action from any court or arbitrator or other governmental or regulatory authority or third party alleging that any services, products, operations or activities of the Company or any of its subsidiaries is in material violation of any Health Care Laws nor, to the knowledge of the Company or its subsidiaries, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, demand, inquiry, arbitration or other action threatened. Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, plan of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none of the Company, its subsidiaries or their respective employees, officers, directors, agents or contractors has been excluded, suspended suspended, debarred or debarred disqualified from participation in any federal health care program or, to or disqualified or restricted under the knowledge of Company and its subsidiaries, Health Care Laws or is subject to or has been threatened in writing with an inquiry, claim, investigation, proceeding, proceeding or other similar matter that could would subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors contractors, to exclusion, suspension suspension, debarment, disqualification or debarmentrestriction.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45(39) above, neither the Company nor any of its subsidiarieslicensees (if any), nor any of their respective employees, officers, directors and agents, nor any of their respective its business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “"Health Care Laws” " means: (i) the Federal U.S. Food, Drug, Drug and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribersindividuals; (iv) the U.S. Controlled Substances Act; (v) any laws or regulations that govern participation in or coverage or reimbursement from any Titles XVIII and XIX of the U.S. or state health care program, including but not limited to Social Security Act and the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (viii) quality, safety and accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (viiix) any and all other applicable health care laws laws, regulations, manual provisions, policies and regulations administrative guidance in any jurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors, agents or contractors has been excluded, suspended or debarred from participation in any federal health care program or, to the knowledge of Company and its subsidiaries, is subject to an inquiry, investigation, proceeding, or other similar matter that could subject the Company, any of its subsidiaries, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting the generality of subsection 1(a)(45) aboveThe Company and its subsidiaries are, neither the Company nor any of its subsidiariesand at all times have been, nor any of their respective employees, officers, directors and agents, nor any of their respective business operations, is in violation of any applicable compliance with all Health Care Laws, except where the failure to do so would not reasonably be in compliance would not, individually or in the aggregate, result in expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder(“FDCA”), including the U.S. Prescription Drug Marketing Act of 1987, as amended21 U.S.C. §301 et seq., and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, including the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the federal criminal false claims law (42 U.S.C. § 1320a-7b), the federal civil monetary penalties law (42 U.S.C. § 1320a-7a), the U.S. Civil civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 the Xxxxx Law (42 U.S.C. § 1395nn), the exclusion laws (42 U.S.C. § 1320a-7), all applicable federal, state, local and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA, (ii) the U.S. Health Insurance Portability statutes, regulations and Accountability Act directives of 1996 (“HIPAA”)applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iviii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)HITECH Act, and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010 (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111-152), the regulations promulgated thereunder; (v) any laws or regulations that govern participation in or coverage or reimbursement from any the U.S. or state health care program, including but not limited to the federal TRICARE statute Controlled Substances Act (10 21 U.S.C. §1071 Section 801 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) quality, safety and accreditation standards and requirements of any under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any Medicare, Title XVIII of the Social Security Act, Medicaid, Title XIX of the Social Security Act; and (viii) all other applicable health care laws local, state, federal, national, supranational and regulations foreign laws, relating to the regulation of the Company or its subsidiary. Except as otherwise disclosed in any jurisdiction, as well as contractual agreements mandated by such laws. Additionallythe SEC Documents, neither the Company nor any of its subsidiariessubsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all required and material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, plans of correction, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Company and its subsidiariesthe Company, is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Without limiting Except as described in the generality of subsection 1(a)(45) aboveRegistration Statement, neither the Company nor any of its subsidiaries, nor any of their respective employees, officers, directors Prospectus and agents, nor any of their respective business operations, is in violation of any applicable Health Care Laws, the Pricing Disclosure Package or except where the failure to be in compliance as would not, individually or in the aggregate, result in be reasonably expected to have a Material Adverse Effect, each of the Company, its subsidiaries and the JVs is, and at all times has been, in compliance with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health care program. For purposes of this Agreement, “Health Care Laws” means: means all Applicable Laws of any Governmental Entity pertaining to health care regulatory matters applicable to the operations of the Company, its subsidiaries or its JVs, including (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) all federal, state, state and local and all foreign health care related fraud and abuse laws, including, without limitation, state corporate practice of medicine laws and regulations, state professional fee-splitting laws and regulations, state workers’ compensation laws and regulations, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7 and 1320a-7a of Title the criminal False Claims Law (42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under HIPAA (as defined below), the U.S. exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), each as amended, and the implementing rules and regulations promulgated pursuant to such statutes; (ii) Medicare (Title XVIII of the Social Security Act); (iii) Medicaid (Title XIX of the Social Security Act), and the regulations promulgated thereunder; (iv) (a) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information1996, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.)§§ 1320d-1329d-8, as amended by the Health Information Technology for Economic and Clinical Health Act, enacted as Title XIII of the American Recovery and Reinvestment Act of 2009, Public Law 111-5 (42 U.S.C. Section 17921 et seq.“HIPAA”), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (ivb) all applicable implementing laws and regulations; and (c) any similar state and local Applicable Laws regarding data protection, data processing, data privacy, data security and/or the U.S. Controlled Substances Actcollection, use, storage, disclosure or cross-border transfer of personal data and information, including protected health information (collectively, including HIPAA, the “Data Privacy and Security Laws”); (v) any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care programand federal controlled substance and drug diversion laws, including but not limited to the federal TRICARE statute Federal Controlled Substances Act (10 21 U.S.C. §1071 § 801, et seq.), ) and the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and any regulations promulgated thereunder; (vi) qualitythe Clinical Laboratory Improvement Amendments of 1988, safety 42 U.S.C. § 263a et seq.; (vii) any Applicable Law pertaining to or regulating the provision or administration of, or payment for, healthcare products and services (such services include physician and allied professional services and related ancillary services); (viii) and Applicable Law regulating the ownership or operation of a health care facility or business, or assets used in connection therewith, including licensing, certification and/or accreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodiesrequirements; and (viiix) any and all other applicable health care laws and regulations regulations, each as amended from time to time, applicable to the operations of the Company, its subsidiaries or its JVs. Except as described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any jurisdictionsubsidiary or any of the JVs has received written notice from any Governmental Entity of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action alleging that any of the Company, the subsidiaries or the JVs is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Except as well as contractual described in the Registration Statement, the Prospectus and the Pricing Disclosure Package, none of the Company, any subsidiary or any of the JVs is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements mandated with or imposed by such lawsany Governmental Entity. Additionally, neither none of the Company nor any of Company, its subsidiaries, or the JVs nor any of their respective employees, officers, directors, agents officers or contractors directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or, to the knowledge of Company and its subsidiaries, or is subject to an a governmental inquiry, investigation, proceeding, or other similar matter action that could subject the Companyreasonably be expected to result in debarment, any of its subsidiariessuspension, or any of their respective employees, officers, directors, agents or contractors to exclusion, suspension or debarment.